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Follow-up Evaluation of Home Nurse Visitation Program for Socially Disadvantaged Women and Their Children

2021年6月8日 更新者:University of Colorado, Denver

Age-27 Follow-up of Early Preventive Intervention

This study will evaluate the long-term effects of a prenatal and early childhood home nurse visitation program for socially disadvantaged women and their children.

調査の概要

詳細な説明

Nearly half a million children are born each year to single, low-income mothers. Children born to socially disadvantaged mothers are more likely to experience chronic health problems, encounter child abuse and neglect, and receive insufficient health care. Home visitation by nurses during pregnancy and early childhood may prevent a wide range of health and developmental problems in children born to women who are either teenagers, unmarried, or of low economic status.

This study is associated with a home nurse visitation program that first began with 400 socially disadvantaged pregnant women between the years of 1977 and 1980 in an upstate New York semi-rural county. Participants in the original study were randomly assigned to participate in the home nurse visitation program or receive comparison services from pregnancy until the child's second birthday. Participants assigned to receive comparison services were provided with free transportation for prenatal and child care, as well as sensory and developmental screening for the child. Participants assigned to the home nurse visitation program were visited at home by a nurse 9 times during pregnancy and 23 times during the child's first 2 years of life. A follow-up study concluded that the home nurse visitation program reduced the number subsequent pregnancies, use of welfare, child abuse and neglect, and criminal behavior on the part of the socially disadvantaged mothers for up to 15 years after the birth of their first child.

This follow-up study will determine whether a home nurse visitation program has continued long-term effects on a child's health and development, 27 years later. Specifically, this study will evaluate whether the nurse-visited young adult offspring differ from the comparison group in their economic productivity; rates of child abuse and neglect; criminal behavior; mental health; abuse of substances; use of welfare, foster care, and healthcare in relation to government expenditures; and quality of their partnered relationships. Participants within the nurse-visited program group will be compared with each other to determine whether certain characteristics or factors, such as genetic vulnerabilities, environmental risks, or a history of child abuse, make someone less likely to benefit from a home nurse visitation program.

研究の種類

介入

入学 (予想される)

345

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • New York
      • Elmira、New York、アメリカ、14901
        • Comprehensive Interdisciplinary Development Services (CIDS)

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

27年~35年 (大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Offspring of mothers who had participated in Elmira, N.Y. randomized clinical trial of prenatal and infant/toddler home visiting by nurses.
  • Participants needed to be at least 27 years of age.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ:発達スクリーニング
参加者は、生後 12 か月と 24 か月の時点で、感覚的および発達的なスクリーニングと、疑わしい問題のさらなる評価と治療のための紹介を受けました。
Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at ages 12 and 24 months of age
アクティブコンパレータ:スクリーニングと交通費
参加者は、生後 12 か月と 24 か月の時点で、感覚的および発達的なスクリーニングと、疑わしい問題のさらなる評価と治療のための紹介を受けました。彼らの母親は、定期的な出生前および育児のための無料送迎を受けました (2 歳までの子供まで)。
Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at ages 12 and 24 months of age
Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at 12 and 24 months of age; their mothers were provided with free transportation for prenatal and well-child care through child age 2.
アクティブコンパレータ:スクリーニング、輸送、出生前の訪問
参加者は、生後 12 か月と 24 か月の時点で、感覚的および発達的なスクリーニングと、疑わしい問題のさらなる評価と治療のための紹介を受けました。彼らの母親は、定期的な出生前ケアと育児ケア (2 歳までの子供) のための無料の交通手段と、妊娠中のナースホーム訪問を受けました。
Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at ages 12 and 24 months of age
Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at 12 and 24 months of age; their mothers were provided with free transportation for prenatal and well-child care through child age 2.
Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at 12 and 24 months of age; their mothers were provided with free transportation for prenatal and well-child care through child age 2, and were provided an average of 9 home visits by nurses during pregnancy.
実験的:スクリーニング、輸送、出生前/Inf 訪問
参加者は、定期的な感覚および発達のスクリーニングと、12 か月齢および 24 か月齢での疑いのある問題のさらなる評価と治療のための紹介を受けました。彼らの母親は、定期的な出生前ケアと育児ケア (2 歳までの子供) のための無料の交通手段と、妊娠中および 2 歳の子供までのナースホーム訪問を受けました。
Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at ages 12 and 24 months of age
Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at 12 and 24 months of age; their mothers were provided with free transportation for prenatal and well-child care through child age 2.
Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at 12 and 24 months of age; their mothers were provided with free transportation for prenatal and well-child care through child age 2, and were provided an average of 9 home visits by nurses during pregnancy.
Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at 12 and 24 months of age; their mothers were provided with free transportation for prenatal and well-child care through child age 2, and were provided an average of 9 home visits by nurses during pregnancy and 23 during the child's first two years of life.

この研究は何を測定していますか?

主要な結果の測定

結果測定
時間枠
Economic productivity (e.g., unemployment, employment in jobs with limited opportunities for career growth, use of welfare, rates of out-of-wedlock births)
時間枠:Measured when child turns 27 years old
Measured when child turns 27 years old
Quality of partnered relationships (violence, commitment, and communication)
時間枠:Measured when child turns 27 years old
Measured when child turns 27 years old
Rates of child abuse and neglect
時間枠:Measured when child turns 27 years old
Measured when child turns 27 years old
Rates of criminal behavior, arrests, convictions, and imprisonment
時間枠:Measured when child turns 27 years old
Measured when child turns 27 years old
Mental health and abuse of substances
時間枠:Measured when child turns 27 years old
Measured when child turns 27 years old
Government expenditures and higher tax revenues
時間枠:Measured when child turns 27 years old
Measured when child turns 27 years old

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:David L. Olds, PhD、University of Colorado, Denver
  • スタディディレクター:John Eckenrode, PhD、Cornell University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2004年9月1日

一次修了 (予想される)

2021年12月1日

研究の完了 (予想される)

2021年12月1日

試験登録日

最初に提出

2007年3月2日

QC基準を満たした最初の提出物

2007年3月5日

最初の投稿 (見積もり)

2007年3月6日

学習記録の更新

投稿された最後の更新 (実際)

2021年6月10日

QC基準を満たした最後の更新が送信されました

2021年6月8日

最終確認日

2021年6月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 04-0002
  • DSIR 84-CTP (NIH)
  • R01MH070761 (米国 NIH グラント/契約)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

We plan to share individual participant data once the primary reports on this phase of the trial are published. This includes baseline data on maternal characteristics at registration during pregnancy and outcome data on primary outcomes for offspring participants at the 27-year follow-up. Data will be made available through the University of Michigan Inter-University Consortium for Political and Social Research (ICPSR). We anticipate archiving the data from this study with ICPSR by March 2018

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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